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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Rusch 1999.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Dolasetron (Group D)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 32

  • Age (mean ± SD, median (IQR), median (range)): 35 ± 8

  • Weight (mean ± SD, median (IQR), median (range)): 66 ± 11

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 50

  • History of PONV/motion sickness (%): 21.88

  • Type of general anaesthesia: balanced anaesthesia (desflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 87

  • Use of perioperative opioids (if yes, which?): 0.16 mg fentanyl intraoperative, 3 patients received piritramide as rescue analgesic

  • Type of surgery: elective laparoscopic surgery


Metoclopramide (Group M)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 33

  • Age (mean ± SD, median (IQR), median (range)): 33 ± 7

  • Weight (mean ± SD, median (IQR), median (range)): 62 ± 11

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 60.61

  • History of PONV/motion sickness (%): 27.27

  • Type of general anaesthesia: balanced anaesthesia (desflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 99

  • Use of perioperative opioids (if yes, which?): 0.16 mg fentanyl intraoperative, 1 patient received piritramide as rescue analgesic

  • Type of surgery: elective laparoscopic surgery


Placebo (Group P)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 32

  • Age (mean ± SD, median (IQR), median (range)): 32 ± 9

  • Weight (mean ± SD, median (IQR), median (range)): 63 ± 9

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 50

  • History of PONV/motion sickness (%): 18.75

  • Type of general anaesthesia: balanced anaesthesia (desflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 104

  • Use of perioperative opioids (if yes, which?): 0.17 mg fentanyl intraoperative, 6 patients received piritramide as rescue analgesic

  • Type of surgery: elective laparoscopic surgery


Included criteria: ASA I and II, women 18 to 55 years of age, scheduled for elective laparoscopic (pelviscopy) surgery
Excluded criteria: pregnancy or breastfeeding, known allergy to one of the used drugs, gastrointestinal infection during the last 2 weeks, intake of antiemetic drugs within the past 24 hours, extreme underweight or overweight (± 30% of the Broca‐Index), communication problems (e.g. lack of German language skills)
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no
Interventions Intervention characteristics
Dolasetron (Group D)

  • Dose: 12.5 mg

  • Time point of administration: 20 minutes before end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (1) 62.5 mg dimenhydrinate 12.5%; (2) 10 mg metoclopramide 3.125%; (3) 1.25 mg droperidol


Metoclopramide (Group M)

  • Dose: 10 mg

  • Time point of administration: 20 minutes before end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (1) 62.5 mg dimenhydrinate 15.15%; (2) 10 mg metoclopramide 3.03%; (3) 1.25 mg droperidol


Placebo (Group P)

  • Dose: NaCl

  • Time point of administration: 20 minutes before end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (1) 62.5 mg dimenhydrinate 31.25%; (2) 10 mg metoclopramide 9.375%; (3) 1.25 mg droperidol.
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)

  • Outcome type: dichotomous outcome


Extrapyramidal symptoms (0 to 24 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)

  • Outcome type: general notes on side effects
Identification Sponsorship source: NA
Country: Germany
Setting: inpatient, single‐centre
Author's name: Dirk Rüsch
Institution: Klinik für Anästhesiologie und Operative Intensivmedizin der Christian‐Albrechts‐Universität zu Kiel
Email: wulf@anaesthesie.uni‐kiel.de
Address: Klinik für Anästhesiologie und Operative Intensivmedizin der Christian‐Albrechts‐Universität zu Kiel, Schwanenweg 21, D‐24105 Kiel
Duration of study: NA
Language: German (2 German reviewers)
Study's primary outcome: incidence of PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "erfolgte gemäß Randomisierungsliste"
Judgement comment: random number table
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("doppel‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "ohne Kenntnis des jeweils applizierten Antiemetikums – folgende Parameter erfaßt"
Judgement comment: outcome assessment was done by blinded observers
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "patientinnen pro Gruppe angestrebt. Von den ursprünglich 40 Patientinnen jeder Studiengruppe konnten infolge Wechselns auf offene Laparotomie, Abweichens der Narkoseführung von dem im Studienprotokoll vorgesehenen Procedere, unvollständig oder fehlerhaft ausgefüllter Studienprotokolle und Entlassung der Patientinnen vor Ende des Beobachtungszeitraums letzlich nur 32 (Gruppe D und ‐P) bzw. 33 (Gruppe M) Patientinnen in die Auswertung einbezogen werden. Verglichen mit der durchschnittlich vorausgesagten"
Judgement comment: high rate of missing data (19%). Reasons described and probably unrelated to the outcomes of interest
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Low risk Quote: "antiemetika widerspiegelte (s. Tabelle 2). Wie aus Tabelle 1 ersichtlich, waren die Studiengruppen bezüglich ihrer biometrischen Daten und der prä‐ und intraoperativ erhobenen Variablen mit Einfluß auf PONV vergleichbar. Bezüglich der Häufigkeit von post..."
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no